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A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses
Sponsor: Biotech Healthcare Holding Gmbh
Summary
Primary Objective: To compare the efficacy and the residual refractive error of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patient with co-existing astigmatism. Secondary Objectives: To evaluate and compare the safety of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patients with co-existing astigmatism.
Official title: A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses to Compare Outcomes in Patients With Moderate to High Myopia and Astigmatism
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
172
Start Date
2021-10-10
Completion Date
2027-02
Last Updated
2025-02-21
Healthy Volunteers
No
Interventions
EYECRYLTM Phakic Toric Intraocular Lens Treatment Arm
The patients will be implanted with Eyecryl Phakic IOL at this arm based on randomization.Phakic intraocular lenses are clear implantable lenses that are surgically placed either in anterior chamber (AC) or posterior chamber (PC) without removing the natural lens, enabling light to focus on the retina for improved uncorrected visual acuity. Phakic intraocular lenses demonstrate high optical quality and potential gain in visual acuity in myopic patients due to retinal magnification. Toric version of phakic intraocular lens is intended to correct both myopia and astigmatism.
Visian® Toric ICL Treatment Arm
The patients will be implanted with Visian® Toric Implantable Contact Lens at this arm based on randomization. Phakic intraocular lenses are clear implantable lenses that are surgically placed either in anterior chamber (AC) or posterior chamber (PC) without removing the natural lens, enabling light to focus on the retina for improved uncorrected visual acuity. Phakic intraocular lenses demonstrate high optical quality and potential gain in visual acuity in myopic patients due to retinal magnification. Toric version of phakic intraocular lens is intended to correct both myopia and astigmatism.
Locations (4)
Precise Vision Augentagesklinik Greven
Münster, North Rhine-Westphalia, Germany
Precise Vision Augentagesklinik Rheine
Rheine, North Rhine-Westphalia, Germany
Precise Vision Augentagesklinik Rheine
Steinfurt, North Rhine-Westphalia, Germany
Netradhama Superspeciality Eye Hospital
Bangalore, Karnataka, India